Overview
Element has a current opening for a Quality Supervisor to join our growing team in Santa Fe Springs, CA.
The Quality Supervisor is responsible for overseeing the day-to-day QA operations within a GMP-regulated pharmaceutical environment, ensuring full compliance with applicable regulations, client requirements, and internal quality standards. Acting as a key link between the laboratory teams and the Quality Manager, this role ensures that all testing activities are executed with accuracy, efficiency, and in alignment with established procedures.
Serving as the bridge between the laboratory operations and Quality leadership, the Quality Supervisor facilitates effective communication, coordinates priorities, and ensures that quality expectations are clearly understood and consistently met across all functional areas. This includes timely review of analytical data, oversight of documentation, management of laboratory investigations such as deviations, Out of Specifications, and CAPAs, and preparation for client and regulatory audits. The Quality Supervisor n ot only ensures that the lab is audit-ready at all times but also drives continuous improvement initiatives, fostering a proactive quality culture. This includes implementing corrective and preventive actions (CAPAs), monitoring their effectiveness, and embedding lessons learned into SOPs and workflows to prevent recurrence.
The position demands both technical expertise and strong leadership skills to guide the QA team in supporting multiple labs, resolving operational quality issues promptly, and driving continuous improvement initiatives. The Quality Supervisor will play a pivotal role in maintaining audit readiness, reinforcing a culture of compliance, and ensuring that the laboratory's output meets the highest scientific and regulatory standards. The role requires a deep understanding of GMP, ISO 17025, FDA, and ICH requirements, as well as the ability to apply these standards to real-world laboratory scenarios.
$85k-$105k DOE
Responsibilities
Oversee day-to-day QA operations, ensuring timely and compliant review of data, reports, and Quality Assurance Data Packages generation.
Act as the primary liaison between laboratory staff and the Quality Manager to ensure alignment on priorities and deliverables
Supervise QA personnel, assigning tasks, monitoring performance, and providing training and mentorship
Collaborate, review, and approve SOPs, test methods, validation protocols, equipment qualifications, calibrations, verifications, and related documentation
Coordinate and support internal, client, and regulatory audits, ensuring readiness and managing follow-up actions
Lead and support investigations into deviations, OOS/OOT results, and client complaints, ensuring thorough root cause analysis and effective CAPA implementation
Monitor compliance with GMP, GDP, ISO 17025, and client-specific requirements
Facilitate effective cross-departmental communication to resolve quality issues and remove workflow barriers
Promote and implement continuous improvement initiatives to enhance operational efficiency and regulatory compliance
Support the implementation and monitoring of eQMS activities
Performs other related duties as assigned
Skills / Qualifications
Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or a related discipline (advanced degree preferred)
Minimum 5 years of experience in a GMP-regulated pharmaceutical or contract laboratory, with at least 2 years in a supervisory QA role
Strong knowledge of GMP, ISO 17025, FDA, EMA, and ICH guidelines
Experience in reviewing analytical data, method validations, and technical reports
Proficiency with Quality Management Systems (QMS), LIMS, and electronic document control systems
Strong leadership, coaching, and team management skills
Excellent communication and interpersonal abilities to effectively bridge technical and management teams
Strong problem-solving skills with the ability to make sound, timely decisions in a fast-paced environment
Detail-oriented with a commitment to accuracy, compliance, and data integrity
Excellent organizational skills and attention to detail
Ability to function well in a high-paced and, at times, a stressful environment
Proficient with Microsoft Office Suite related software
LI-TK1
Company Overview
Element is one of the fastest growing testing, inspection and certification businesses in the world. Globally we have more than 9,000 brilliant minds operating from 270 sites across 30 countries. Together we share an ambitious purpose to 'Make tomorrow safer than today'.
When failure in use is not an option, we help customers make certain that their products, materials, processes and services are safe, compliant and fit for purpose. From early R&D, through complex regulatory approvals and into production, our global laboratory network of scientists, engineers, and technologists support customers to achieve assurance over product quality, sustainable outcomes, and market access.
While we are proud of our global reach, working at Element feels like being part of a smaller company. We empower you to take charge of your career, and reward excellence and integrity with growth and development.
Industries across the world depend on our care, attention to detail and the absolute accuracy of our work. The role we have to play in creating a safer world is much bigger than our organization.
Diversity Statement
At Element, we always take pride in putting our people first. We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our Vision of becoming "the world's most trusted testing partner".
All suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws or other characteristics in accordance with the applicable governing laws.
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
"If you need an accommodation filling out an application, or applying to a job, please email Recruitment@element.com "
Job Locations US-CA-Santa Fe Springs
ID 2025-17319
